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ACTIVE NOT RECRUITING
NCT03555422
PHASE3

Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]

Sponsor: Karyopharm Therapeutics Inc

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.

Official title: A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

263

Start Date

2018-01-05

Completion Date

2025-12

Last Updated

2025-01-20

Healthy Volunteers

No

Interventions

DRUG

Selinexor

Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

DRUG

Matching placebo for selinexor

Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral

Locations (78)

Arizona Oncology

Tucson, Arizona, United States

Stanford University

Palo Alto, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Florida Cancer Specialists (Sarah Cannon Research Institute)

West Palm Beach, Florida, United States

Gynecological Cancer Institute of Chicago

Oak Lawn, Illinois, United States

Parkview Research Center

Fort Wayne, Indiana, United States

Indiana University Simon Cancer Center

Indianapolis, Indiana, United States

HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)

Kansas City, Missouri, United States

NYU Langone

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Oklahoma Health Sciences Center - Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oncology Associates of Oregon

Eugene, Oregon, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Tennessee Oncology Nashville (Sarah Cannon Research Institute)

Nashville, Tennessee, United States

Texas Oncology, Austin

Austin, Texas, United States

Texas Oncology DFW

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Oncology DFW

Fort Worth, Texas, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

UZ Gent

Ghent, Belgium

Jan Yperman Ziekenhuis

Ieper, Belgium

Universitaire Ziekenhuizen K.U. Leuven

Leuven, Belgium

CHU UCL Namur, Site Sainte-Elisabeth

Namur, Belgium

AZ Turnhout

Turnhout, Belgium

CHR Verviers

Verviers, Belgium

London Health Sciences Centre (London Regional Cancer Centre)

London, Ontario, Canada

University Health Network (PMCC)

Toronto, Ontario, Canada

McGill University Health Centre (MUHC)

Montreal, Quebec, Canada

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangxi Maternal and Child Health Hospital

Nanchang, Jiangxi, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Chongqing University Cancer Hospital

Chongqing, Shapingba District, China

Wenzhou Medical University - The First Affiliated Hospital

Wenzhou, Zhejiang, China

University Hospital Brno

Brno, Czechia

University Hospital Ostrava

Ostrava, Czechia

UH Královské Vinohrady

Prague, Czechia

General University Hospital in Prague

Prague, Czechia

Hospital Na Bulovce

Prague, Czechia

Charite Berlin Universitatsmedizin

Berlin, Germany

University Hospital Dresden

Dresden, Germany

DIAKOVERE KH gGmbH, Henriettenstift Hannover

Hanover, Germany

Universitatsklinikum Schleswig-Holstein

Kiel, Germany

Universitätsfrauenklinik Mainz

Mainz, Germany

Klinikum der Universitat Munchen

Munich, Germany

Cartitas Klinikum Saarbrücken

Saarbrücken, Germany

Universitätsfrauenklinik Ulm

Ulm, Germany

Iaso Hospital

Marousi, Athens, Greece

ALEXANDRA Hospital

Athens, Greece, Greece

Euromedica General Clinic

Thessaloniki, Macedonia, Greece

Hillel Yaffe Medical Center

Hadera, Israel

Wolfson Medical Center

Holon, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Hadassah Medical Center

Jerusalem, Israel

Sheba Medical Center

Ramat Gan, Israel

Istituto di Candiolo, FPO, IRCCS

Candiolo, Italy

Romagnolo Scientific Institute for the Study and Treatment of Tumors

Meldola, Italy

San Raffaele Hospital

Milan, Italy

Istituto Nazionale dei Tumori IRCCS - MILANO S.C. Ginecologia Oncologica

Milan, Italy

ULSS 3 SERENISSIMA UOC Oncologia Ed Ematologia Oncologica

Mirano, Italy

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica

Naples, Italy

Agostino Gemelli University Polyclinic Foundation

Rome, Italy

Hospital Universitario Donostia

San Sebastián, Gipuzkoa, Spain

Hospital Universitari Vall d' Hebrón

Barcelona, Spain

Hospital Universitari Clínic de Barcelona

Barcelona, Spain

Consorci Sanitari de Terrassa

Barcelona, Spain

Hospital Universitario Ramón y Cajal

Madrid, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Madrid, Spain

Hospital Universitario Infanta Sofía

Madrid, Spain

Virgen de la Arrixaca University Clinical Hospital

Murcia, Spain

Hospital Son Llàtzer

Palma, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Instituto Valenciano de Oncología

Valencia, Spain

Hospital Clínico Universitario de Valencia

Valencia, Spain

Hospital Universitario y Politécnico de La Fe

Valencia, Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain